Recall archive / FDA device enforcement

Incisive CT; Software Version Number: 4.5, 5.0, 5.1; — FDA record Z-0881-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 29, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Incisive CT; Software Version Number: 4.5, 5.0, 5.1;
Reason: If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.
Classification: Class II
Recalling firm: Philips North America Llc
Quantity: 2341 units
Agency-reported status: Ongoing
Source record identifier: Z-0881-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	1) Model Number: 728143; UDI-DI: 00884838085015; Serial Numbers: 500092, 500202, 500309, 500376, 500574, 500265, 500264, 510051, 500034, 500544, 500543, 500548, 500046, 500168, 500064, 500110, 500111, 500102, 500145, 500178, 500255, 500217, 500211, 500216, 500225, 33009, 500242, 500252, 500222, 500282, 33005, 500301, 33001, 33035, 33039, 33002, 33003, 33007, 33013, 33047, 33011, 33008, 33015, 33020, 33010, 33046, 33017, 33019, 33049, 33016, 33024, 33006, 33025, 33034, 33041, 33038, 33031, 33042, 33033, 33037, 33045, 33012, 500032, 500073, 500138, 500308, 33023, 500443, 500410, 500412, 500557, 500038, 500069, 500332, 500397, 510056, 500091, 500135, 510028, 510029, 500591, 500123, 500087, 500136, 500103, 500116, 500105, 500056, 500125, 500041, 500089, 500200, 500152, 500219, 500256, 500213, 500307, 510001, 500233, 500371, 500370, 500377, 510030, 510032, 510031, 500360, 510005, 510020, 500329, 500361, 500436, 500457, 500406, 500465, 500525, 500535, 510027, 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550076, 550319, 550190, 550230, 550231, 550374, 550126, 34002, 34006, 34007, 34025, 34026, 34018, 34023, 34031, 34033, 34032, 34038, 34041, 34042, 34040, 34051, 34047, 34050, 34049, 34052, 34053, 34054, 34056, 34057, 34055, 34060, 34058, 34059, 34064, 34066, 34072, 34067, 34068, 34071, 34074, 34073, 34078, 34079, 34075, 34077, 34082, 34081, 34083, 34085, 34088, 34090, 34086, 34092, 34091, 34093, 34089, 34112, 34095, 34103, 34097, 34100, 34106, 34102, 34101, 34105, 34111, 34117, 34119, 34116, 34134, 34131, 34133, 34122, 34132, 34137, 34135, 550243, 34126, 34149, 34146, 34128, 34150, 34164, 34162, 34165, 34168, 34169, 34174, 34179, 34187, 34190, 34198, 34195, 34193, 34203, 34191, 34201, 34206, 34208, 34163, 34152, 34160, 34221, 34218, 34226, 34235, 34223, 34240, 34229, 34251, 34153, 34175, 34257, 34259, 34260, 34263, 34265, 34267, 34276, 34277, 34282, 34280, 34279, 34281, 34285, 34294, 34315, 34301, 34324, 34327, 34325, 34289, 34338, 34326, 34337, 34351, 500452, 550016, 550040, 34001, 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550317, 550322, 552113, 552001, 550017, 550055, 55202...

Label field

Details supplied by the agency

Lot, code or applicability

1) Model Number: 728143; UDI-DI: 00884838085015; Serial Numbers: 500092, 500202, 500309, 500376, 500574, 500265, 500264, 510051, 500034, 500544, 500543, 500548, 500046, 500168, 500064, 500110, 500111, 500102, 500145, 500178, 500255, 500217, 500211, 500216, 500225, 33009, 500242, 500252, 500222, 500282, 33005, 500301, 33001, 33035, 33039, 33002, 33003, 33007, 33013, 33047, 33011, 33008, 33015, 33020, 33010, 33046, 33017, 33019, 33049, 33016, 33024, 33006, 33025, 33034, 33041, 33038, 33031, 33042, 33033, 33037, 33045, 33012, 500032, 500073, 500138, 500308, 33023, 500443, 500410, 500412, 500557, 500038, 500069, 500332, 500397, 510056, 500091, 500135, 510028, 510029, 500591, 500123, 500087, 500136, 500103, 500116, 500105, 500056, 500125, 500041, 500089, 500200, 500152, 500219, 500256, 500213, 500307, 510001, 500233, 500371, 500370, 500377, 510030, 510032, 510031, 500360, 510005, 510020, 500329, 500361, 500436, 500457, 500406, 500465, 500525, 500535, 510027, 500523, 33043, 500028, 500024, 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530127, 530140, 530095, 530115, 530129, 530108, 530142, 530138, 530144, 530141, 530133, 530128, 530302, 530181, 530167, 530182, 530217, 530149, 530246, 530145, 530304, 530219, 530151, 530148, 530283, 530150, 530122, 530173, 530211, 530110, 530216, 530166, 530170, 530153, 530218, 530164, 530221, 530168, 530299, 530322, 530158, 530223, 530157, 530162, 530184, 530206, 530180, 530163, 530143, 530210, 530177, 530188, 530198, 530205, 530240, 530215, 530268, 530214, 530232, 530245, 530230, 530231, 530417, 530321, 530190, 530192, 530194, 530169, 530193, 530213, 530123, 530395, 530156, 530209, 530197, 530196, 530183, 530248, 530247, 530237, 530228, 530313, 530251, 530242, 530265, 530258, 530281, 530593, 530341, 530270, 530286, 530261, 530542, 530267, 530284, 530199, 530276, 530224, 530340, 530239, 530279, 530271, 530235, 530277, 530243, 530262, 530377, 530259, 530278, 530289, 530391, 530288, 530249, 530364, 530285, 530381, 530257, 530260, 530392, 530295, 530305, 530314, 530297, 530333, 530266, 530312, 530290, 530310, 530309, 530327, 530292, 530355, 530324, 530411, 530308, 530323, 530274, 530356, 530371, 530343, 530315, 530325, 530579, 530287, 530574, 530352, 530386, 530383, 530336, 530334, 530382, 530402, 530367, 530375, 530347, 530365, 530444, 530390, 530361, 530418, 530447, 530351, 530346, 530441, 530366, 530410, 530572, 530451, 530478, 530434, 530422, 530423, 530376, 530477, 530429, 530380, 530412, 530359, 530403, 530413, 530414, 530594, 530393, 530405, 530469, 530416, 530471, 530379, 530387, 530385, 530406, 530397, 530440, 530433, 530442, 530424, 530450, 530571, 530394, 530396, 530400, 530399, 530401, 530398, 530426, 530425, 530445, 530454, 530465, 530427, 530497, 530472, 530457, 530428, 530496, 530453, 530467, 530448, 530455, 530438, 530536, 530439, 530446, 530479, 530463, 530459, 530526, 530443, 530513, 530468, 530473, 530484, 530566, 530511, 530512, 530485, 530538, 530487, 530488, 530493, 530491, 530495, 530490, 530499, 530498, 530504, 530503, 530505, 530522, 530583, 530517, 530541, 530544, 530516, 530518, 530556, 530520, 530570, 530519, 530560, 530557, 530525, 530532, 530528, 530558, 530587, 530555, 530531, 530540, 530546, 530539, 530548, 530553, 530551, 530568, 530573, 530586, 530582, 530565, 530580, 530590, 530595, 510014, 500396, 500579, 530354, 500193, 500098, 500327, 500419, 500420, 500388, 500093, 500355, 500380, 510053, 500070, 500065, 500261, 500441, 510012, 500432, 500006, 500447, 500580, 500620, 500304, 500587, 500117, 500404, 500366, 500417, 500007, 500025, 500022, 500033, 500037, 500057, 500027, 500151, 500408, 500050, 500063, 500072, 500094, 500147, 500148, 500398, 500243, 500236, 500246, 500260, 500277, 500335, 510000, 500315, 500369, 500389, 500381, 500466, 500475, 500547, 510054, 500021, 500115, 500053, 500095, 500077, 500170, 500362, 500560, 500230, 500573, 500582; 2) Model Number: 728144; UDI-DI: 00884838105508; Serial numbers: 552070, 552094, 34415, 34010, 552036, 550138, 550133, 552051, 550320, 550076, 550319, 550190, 550230, 550231, 550374, 550126, 34002, 34006, 34007, 34025, 34026, 34018, 34023, 34031, 34033, 34032, 34038, 34041, 34042, 34040, 34051, 34047, 34050, 34049, 34052, 34053, 34054, 34056, 34057, 34055, 34060, 34058, 34059, 34064, 34066, 34072, 34067, 34068, 34071, 34074, 34073, 34078, 34079, 34075, 34077, 34082, 34081, 34083, 34085, 34088, 34090, 34086, 34092, 34091, 34093, 34089, 34112, 34095, 34103, 34097, 34100, 34106, 34102, 34101, 34105, 34111, 34117, 34119, 34116, 34134, 34131, 34133, 34122, 34132, 34137, 34135, 550243, 34126, 34149, 34146, 34128, 34150, 34164, 34162, 34165, 34168, 34169, 34174, 34179, 34187, 34190, 34198, 34195, 34193, 34203, 34191, 34201, 34206, 34208, 34163, 34152, 34160, 34221, 34218, 34226, 34235, 34223, 34240, 34229, 34251, 34153, 34175, 34257, 34259, 34260, 34263, 34265, 34267, 34276, 34277, 34282, 34280, 34279, 34281, 34285, 34294, 34315, 34301, 34324, 34327, 34325, 34289, 34338, 34326, 34337, 34351, 500452, 550016, 550040, 34001, 34151, 34004, 550035, 34166, 552133, 552034, 550165, 550216, 550218, 550242, 34254, 34306, 552086, 500507, 500537, 550027, 550029, 34044, 550090, 550154, 34129, 550295, 34196, 34156, 34209, 550122, 552135, 552134, 550476, 550019, 552002, 500520, 552000, 510040, 510043, 500536, 550000, 550014, 552017, 550088, 550053, 550089, 552005, 552021, 552043, 550132, 550127, 550105, 550160, 550179, 550292, 550262, 550263, 550264, 550271, 550158, 552029, 552056, 552057, 552058, 552067, 552076, 552075, 552074, 550299, 550361, 550343, 550257, 550304, 550244, 550429, 550413, 550193, 550278, 550256, 550261, 550313, 550297, 552114, 552118, 552117, 552115, 552121, 552110, 552090, 552109, 552105, 552081, 550394, 550431, 550446, 550430, 550455, 550497, 550500, 550481, 550444, 550482, 550451, 550443, 550432, 550485, 550463, 552125, 552129, 552128, 552131, 552130, 552126, 552123, 552127, 550504, 550506, 550513, 550507, 550412, 34043, 34065, 34084, 34061, 34180, 34186, 34211, 34212, 34273, 34317, 34349, 552085, 500502, 510039, 550092, 550104, 550162, 550181, 550185, 550200, 550298, 552104, 34274, 552111, 55400406110846, 500283, 550453, 500340, 500499, 550093, 550096, 34142, 34108, 34161, 34177, 34194, 34219, 34246, 34255, 550251, 34217, 34252, 34147, 34127, 550203, 550296, 550234, 550266, 34157, 550300, 550291, 550248, 34176, 34253, 550301, 34239, 34224, 34227, 34216, 34309, 550111, 550147, 550163, 550362, 550280, 550201, 550202, 550307, 550281, 550283, 550284, 550235, 550387, 550496, 550333, 550414, 550347, 550462, 550419, 550404, 550399, 550356, 550461, 550420, 550458, 550511, 552006, 552007, 552009, 552016, 550091, 552023, 552037, 550353, 550210, 550228, 550240, 552101, 550403, 550489, 550135, 550366, 550021, 552020, 552032, 550087, 550123, 550155, 550418, 550302, 550509, 550078, 550503, 552052, 540020, 540021, 552050, 541001, 550221, 550222, 550223, 550224, 552054, 550253, 552060, 552059, 552062, 550273, 550287, 550288, 550289, 552069, 550439, 550324, 550325, 552065, 550318, 550317, 550322, 552113, 552001, 550017, 550055, 55202...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Ethiopia, France, FrenchPolynesia, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Macedonia, Malaysia, Mauritius, Mexico, Moldova, Montenegro, Montserrat, Morocco, Mozambique, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Papua Nw Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Rwanda, Saint Kitts, Saint Lucia, Saudi Arabia, Serbia, Sint Maarten (D, Slovakia, South Africa, South Korea, Spain, St.Pier,Miquel., Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad,Tobago, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Dec 10, 2025
Recall initiation date: Oct 29, 2025
Center classification date: Dec 3, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records